MEDROL

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

METHYLPREDNISOLONE

제공처:

PFIZER INDONESIA - Indonesia

INN (International Name):

METHYLPREDNISOLONE

복용량:

16 MG

약제 형태:

TABLET

패키지 단위:

DUS, 3 BLISTER @ 10 TABLET

Manufactured by:

PFIZER ITALIA S.R.L - Italy

승인 날짜:

2020-11-23

제품 특성 요약

PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Methylprednisolone tablets
Trade Name: MEDROL
®
CDS Effective Date: June 26, 2019
Supersedes: January 03, 2018
DESCRIPTION
MEDROL
®
Tablets contain methylprednisolone, which is a glucocorticoid.
Glucocorticoids are
adrenocortical steroids but naturally occurring and synthetic, which
are readily absorbed from the
gastrointestinal
tract.
Methylprednisolone
occurs
as
a
white
to
practically
white,
odorless,
crystalline powder. It is sparingly soluble in alcohol, in dioxane,
and in methanol, slightly soluble
in acetone, and in chloroform, and very slightly soluble in ether. It
is practically insoluble in
water.
The
chemical
name
for
methylprednisolone
is
pregna-1,
4-diene-3,
20-dione,
11,
17,
21-
trihydroxy-6-methyl-, (6α, 11β) - and the molecular weight is
374.48. The structural formula is
represented below:
Each MEDROL
®
Tablet for oral administrations contains 4 mg and 16 mg of
methylprednisolone.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Naturally occurring glucocorticoids (hydrocortisone), which also have
salt-retaining properties,
are used as replacement therapy in adrenocortical deficiency states.
Their synthetic analogs are
primarily used for their potent anti-inflammatory effects in disorder
of many organ systems. It has
greater anti-inflammatory potency than prednisolone and less tendency
than prednisolone to
induce sodium and water retention. The relative potency of
methylprednisolone to hydrocortisone
is at least four to one.
DISETUJUI OLEH BPOM : 15/02/2022
EREG100241119000329 -330
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify the body’s
immune responses to diverse stimuli.
PHARMACOKINETIC PROPERTIES
Methylprednisolone pharmacokinetics is linear, independent of route of
administration.
ABSORPTION:
Methylprednisolone
is
rapidly
absorbed
and
the
maximum
plasma
methylprednisolone
concentration is achieved around 1.5 to 2.3 hours across doses
following oral administration in
normal healthy adul